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Completed

NCT Number: NCT02056951

Interprofessional Rehabilitation for Adults With Chronic Non-specific Low Back Pain

The primary aim of the study is to analyse the long-term effectiveness of an interprofessional and interdisciplinary rehabilitation program named "PASTOR", with a biopsychosocial approach for participants with chronic non-specific low back pain (CLBP) compared to the standard inpatient multidisciplinary orthopaedic rehabilitation (MOR) in Germany. The investigators hypothesize that in adults with CLBP the rehabilitation program PASTOR would result in a significantly higher increase in functional ability 12 months after completion of the program in comparison to the standard inpatient MOR. The investigators further hypothesize that PASTOR would lead to significantly larger improvements regarding pain-related cognitions, pain coping strategies, physical activity, health-related quality of life, and back pain episodes compared to the standard inpatient MOR.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Frankenklinik, Bad Kissingen, Bavaria, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • M51.2 Other specified intervertebral disc displacement
  • M51.3 Other specified intervertebral disc degeneration
  • M51.4 Schmorl's nodes
  • M51.8 Other specified intervertebral disc disorders
  • M51.9 Intervertebral disc disorder, unspecified
  • M53.8 Other specified dorsopathies
  • M53.9 dorsopathy, unspecified
  • M54.4 Lumbago with sciatica
  • M54.5 Low back pain
  • M54.6 Pain in thoracic spine
  • M54.8 Other dorsalgia
  • M54.9 Dorsalgia, unspecified

Exclusion criteria

  • age below 18 years or over 65 years
  • specific underlying diagnosis of back pain (e. g. radicular symptoms, myelopathy)
  • considerably reduced health status (e.g. comorbidity)
  • considerably reduced sight and hearing (not corrected)
  • severe psychiatric condition as secondary diagnosis
  • inability to speak German
  • current application for early retirement or invalidity pension (§51 SG V - german law)

Treatment and study plan

Multidisciplinary rehabilitation

Procedure

Multidisciplinary rehabilitation includes interventions from the physical and psychological dimensions:

  • health education
  • exercise therapy
  • back school
  • physical treatments
  • psychological interventions in groups and individual counselling
  • rehabilitation/social counselling.

Interprofessional rehabilitation

Procedure

Interprofessional rehabilitation includes also interventions from the physical and psychological dimensions:

  • education about low back pain
  • behavioural exercise therapy
  • coping with pain
  • relaxation
  • work related informations

Primary outcomes

  1. Change from Baseline in Hannover Functional Ability Questionnaire (FFbH-R) at 12 months

    Time frame: baseline, one year

    The FFbH-R consists of twelve items with a three-stage answering scale (2=yes; 1=yes, but with difficulty; 0=no, or only with assistance). The summary score describes the low back pain associated functional ability in activities of daily living (e.g. "Can you wash and dry yourself from head to toe?") in adults on a scale of 0% (minimum functional ability) to 100% (maximum functional ability).

    Kohlmann Th & Raspe H (1996). Der Funktionsfragebogen Hannover zur alltagsnahen Diagnostik der Funktionsbeeinträchtigung durch Rückenschmerzen (FFbH-R). Die Rehabilitation, 34, I-VIII.

Secondary outcomes

  1. Health-related Quality of Life (SF-12)

    Time frame: baseline, three weeks, one year

    To assess mental and physical health status during the past four weeks.

    Bullinger M & Kirchberger I (1998). SF-36, Fragebogen zum Gesundheitszustand. Göttingen: Hogrefe.

  2. Numerical rating scale (NRS)

    Time frame: baseline, three weeks, one year

    Three items to assess the pain intensity reported by participants at the moment, as well as during the last six months (mean and maximum pain).

    Nagel B, Gerbershagen HU, Lindena G & Pfingsten M (2002). Entwicklung und empirische Überprüfung des Deutschen Schmerzfragebogens der DGSS. Schmerz, 16 (4), 263-270.

  3. Freiburg Questionnaire of physical activity (FFkA)

    Time frame: baseline, one year

    The FQPA measures the amount of physical activity in different contexts performed by the participants: occupational setting (rating: intensive movement, moderate movement, mostly sitting) as well as leisure time physical activity (e.g. gardening, stair-climbing, habitual walking and cycling, sports). It consists of eight items.

    Frey I, Berg A, Grathwohl D & Keul J (1999). Freiburger Fragebogen zur körperlichen Aktivität - Entwicklung, Prüfung und Anwendung. Sozial- und Präventivmedizin, 44, 55-64.

  4. Pain Management Questionnaire (FESV)

    Time frame: baseline, three weeks, one year

    Questionnaire to assess cognitive and behavioral pain coping strategies.

    Geissner E (2001). Fragebogen zur Erfassung der Schmerzverarbeitung (FESV). Manual. Göttingen: Hogrefe.

  5. Avoidance-Endurance Questionnaire (AEQ)

    Time frame: baseline, three weeks, one year

    Questionnaire to assess fear-avoidance response pattern and avoidance-endurance response pattern to pain.

    Hasenbring MI, Hallner D & Rusu AC (2009). Fear-avoidance- and endurance-related responses to pain: development and validation of the Avoidance-Endurance Questionnaire (AEQ). Eur J Pain, 13 (6), 620-628.

  6. Change from Baseline in Hannover Functional Ability Questionnaire (FFbH-R) at 3 weeks

    Time frame: baseline, three weeks

    The FFbH-R consists of twelve items with a three-stage answering scale (2=yes; 1=yes, but with difficulty; 0=no, or only with assistance). The summary score describes the low back pain associated functional ability in activities of daily living (e.g. "Can you wash and dry yourself from head to toe?") in adults on a scale of 0% (minimum functional ability) to 100% (maximum functional ability).

    Kohlmann Th & Raspe H (1996). Der Funktionsfragebogen Hannover zur alltagsnahen Diagnostik der Funktionsbeeinträchtigung durch Rückenschmerzen (FFbH-R). Die Rehabilitation, 34, I-VIII.

Other outcomes

  1. Tampa Scale of Kinesiophobia

    Time frame: baseline, three weeks, one year

    A 17-item self report checklist using a 4-point Likert scale to assess fear of movement/ re-injury.

    Vlaeyen JWS, Kole-Snijders AMJ, Boeren RGB, & Van Eek H (1995). Fear of movement/(re) injury in chronic low back pain and its relation to behavioral performance. Pain, 62(3), 363-372.

    Nigbur K, Rusu A, Hallner D & Hasenbring M (2009). Fear of movement/(re)injury in chronic pain: Preliminary validation of a German version of the Tampa Scale for Kinesiophobia. Poster presented at Pain in Europe - 6th Congress of the European Federation of IASP® Chapters (EFIC), Lisbon 2009.

  2. Patient Health Questionnaire (PHQ)

    Time frame: baseline, three weeks, one year

    Löwe B, Spitzer RL, Zipfel S & Herzog W (2002). Gesundheitsfragebogen für Patienten (PHQ-D). Manual und Testunterlagen (2. Aufl.). Karlsruhe: Pfizer.

  3. Pain Catastrophizing Scale (PCS)

    Time frame: baseline, three weeks, one year

    Meyer K, Sprott H & Mannion AF (2008). Cross-cultural adaptation, reliability, and validity of the German version of the Pain Catastrophizing Scale. J Psychosom Res, 64 (5), 469-478.

  4. Self-control inventory (SSI-L)

    Time frame: baseline, one year

    Fröhlich S & Kuhl J (2003). Das Selbststeuerungsinventar: Dekomponierung volitionaler Funktionen. In: J. Stiensmeier-Pelster & F. Rheinberg (Hrsg.), Diagnostik von Motivation und Selbstkonzept (S. 221-258). Göttingen [u.a.]: Hogrefe.

  5. HAPA variables

    Time frame: baseline, three weeks, one year

    HAPA variables include sets of items about the risk perception, self-efficacy, outcome expectations, intention, action and coping planning, and action control regarding physical activity.

    Sniehotta FF, Scholz U & Schwarzer R (2005). Bridging the intention-behaviour gap: Planning, self-efficacy, and action control in the adoption and maintenance of physical exercise. Psychol Health, 20 (2), 143-160.

    Sniehotta FF, Schwarzer R, Scholz U & Schüz B. (2005). Action planning and coping planning for long-term lifestyle change: Theory and assessment. Eur J Soc Psychol (35), 565-576.

  6. Stage of behavior change

    Time frame: baseline, one year

    Stage assessment of behaviour change contains the question: Have you performed moderate physical for 30 minutes or longer on a minimum of 3 days per week? (rating: No, and I don't intend to do so - No, but I am currently thinking about that - No, but I strongly intend to do so - Yes, but it is difficult to me - Yes and it is easy to me), and a validation item ("Since when are you regularly active as you are now?")

    Lippke S, Ziegelmann J, Schwarzer R & Velicer W (2009). Validity of stage assessment in the adoption and maintenance of physical activity and fruit and vegetable consumption. Health Psychology (28), 183-193.

  7. Graded Chronic Pain Status (GCPS)

    Time frame: baseline, one year

    Six items to assess the number of days with pain during the last six months, the history of pain and the functional disability due to pain (adapted for 6 months).

    Korff M von, Ormel J, Keefe FJ & Dworkin SF (1992). Grading the severity of chronic pain. Pain, 50 (2), 133-149.

  8. Time off work for back pain

    Time frame: baseline, one year

    Self-reported day of sick leave due to low back pain during the last six month

  9. Health care utilization due to low back pain

    Time frame: baseline, one year

    Self-reported health care utilization due to low back pain during the last six months

  10. Job satisfaction

    Time frame: baseline, one year

    A 8-item self report checklist of the IRES using a 5-point Likert scale to assess job satisfaction (ranging from 1="complete agreement" to 5="complete disagreement".

    Bührlen B, Gerdes N & Jäckel WH (2005). Entwicklung und psychometrische Testung eines Patientenfragebogens für die medizinische Rehabilitation (IRES-3). Rehabilitation, 44, 63-74.

Sponsors and collaborators

Lead sponsor

University of Erlangen-Nürnberg

Other

Collaborators

  • Deutsche Rentenversicherung
  • University of Wuerzburg

Registry information

Official study title

Interprofessional Biopsychosocial Rehabilitation to Optimize Inpatient Multidisciplinary Orthopedic Rehabilitation for Chronic Low Back Pain

Acronym: PASTOR

Important dates

Study start
2008
Primary completion
2010
Study completion
2011
First posted
Feb 6, 2014
Registry last updated
Sep 9, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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